First in Human Trial of TAS266 in Patients With Advanced Solid Tumors

NCT ID: NCT01529307

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-09-30

Brief Summary

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This study will assess safety, tolerability, maximum tolerated dose or recommended dose for expansion of TAS266 administered by IV infusion to patients with advanced solid tumors.

Detailed Description

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Conditions

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Advanced Solid Tumors

Keywords

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Biologic, solid tumors, Death Receptor 5 agonist, caspase-8

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAS266

Group Type EXPERIMENTAL

TAS266

Intervention Type DRUG

TAS266 IV infusions given weekly

Interventions

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TAS266

TAS266 IV infusions given weekly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of solid tumors
* 18 years or older
* ECOG performance status of 0, 1 or 2
* Adequate bone marrow, hepatic and renal function
* Obtained written informed consent

Exclusion Criteria

* Patients with primary CNS tumor or CNS tumor involvement. However patients with CNS metastases may be allowed if certain conditions are met.
* Major surgery within 4 weeks before study treatment
* Prior anaphylactic or other severe infusion reactions to human immunoglobulin or antibody formulations
* Impaired cardiac functions
* Previous hepatitis viral infection such as hepatitis B or hepatitis C
* Diagnosis of HIV infection
* Pregnant or nursing (lactating) women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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H. Lee Moffitt Cancer Center/University of South Florida Moffitt SC

Tampa, Florida, United States

Site Status

South Texas Accelerated Research Therapeutics START

San Antonio, Texas, United States

Site Status

University of Utah / Huntsman Cancer Institute Huntsman UT

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=9663

Results for CTAS266X2101 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CTAS266X2101

Identifier Type: -

Identifier Source: org_study_id